This invention relates to a valve for alleviating urinary incontinence. More particularly, the invention is concerned with a patient controlled valve to permit urination and prevent undesirable leakage of urine while allowing relief when needed without removal of the valve from the body of the patient. A most preferred embodiment of the device is for alleviating urinary incontinence, particularly stress incontinence, in a female patient.
Urinary incontinence, which is a condition involving involuntary loss of urine, is a problem with many patients, particularly females, throughout the world. Sometimes the problem is treated with surgery or incontinence pads. Some patients can not receive surgery or suffers only from a partial loss of urine. Those problems may be treated non-surgically by use of internal (intra-urethral or intra-vaginal) or external devices. A number of external female devices have been patented.
For example, U.S. Pat. No. 5,074,855 discloses a device for controlling urinary incontinence in a human female including a resilient pad configured to seal against and occlude the urethral meatus of the user. A similar device is disclosed in U.S. Pat. No. 5,336,208. In those devices, an adhesive is provided to seal the body of the device against the urethral meatus.
International Applications No. 96139989, 96/39990 and 96/39991 each disclose a female urinary incontinence device in the form of an urethral cap with a partially deformable body portion, a hand gripping portion and a body contacting surface. The body portion defines a chamber which allows for a vacuum seal when applied to the patient""s body.
Each of the above devices prevents urinary leakage by occluding the external urethral orifice and each has to be removed by the patient to allow micturition.
It is desirable to have a device which satisfactorily prevents leakage and also facilitates relief without the need to remove the device from the body of the patient. It has now been found that these benefits may be achieved with an easily operable valve which prevents leakage when closed and allows flow when open.
A valve adapted for closing a body orifice most preferably has a bulbous tube formed of a flexible material as its main structure and shape. The bulbous tube may have an inlet fixed across the body orifice and an outlet positioned away from the body orifice for controlling incontinence. A flange located around the inlet of the bulbous tube is used in the preferred embodiment to attach to the body. The flange most preferably has a generally flat ring shaped configuration to circumscribe the inlet and to interface about the body orifice. A passage is formed within and passes through the bulbous tube for extending from the inlet along an axis therethrough between the inlet and outlet. A wall of the bulbous tube is preferably integral therewith. The wall may be located between the inlet and the outlet. Consistent with the configuration the wall may have a barrel shape tapering toward the inlet and the outlet so the bulbous tube is most preferably wider therebetween. The wall can be between an inside and an outside.
A hinge is preferably part of the wall and about the bulbous tube. The hinge might be located in the wall substantially wherein the barrel shape wall defines the passage therethrough. The hinge may exist as an area of preferential bending so the bulbous tube is either normally barrel shaped or flipped with the outlet thereof folded about the hinge and into the passage. While the preferred hinge is, that is either open or closed, the hinge can also be arranged to be normally closed such that to keep it open the outlet must be pulled away from the seat by the user or the pressure of urination force from the bladder down the urethra holding the outlet away from the seat. This can be considered a monostable arrangement for the hinge but the valve would look the same since the bias of the hinge is not really apparent in illustrations.
A seat is preferably positioned within the bulbous tube. The seat can be in the preferred embodiment located on the inside of the wall. The seat may perhaps be disposed within the passage to engage the outlet when the bulbous tube is flipped into the passage after bending the hinge acutely. The outlet is most preferably then moved along the axis toward the inlet so the outlet may be held against the seat to seal the inlet and close the passage.
One or more holes are preferably dispose through the wall. Each hole might be located in a plane substantially normal to the axis and away from the inlet and axially beyond the hinge. The outlet may surround a bottom of the bulbous tube so that when the -flipped bulbous tube moves the bottom axially into the passage, the bottom locates the one or more holes dispose through the wall in contact with the seat and positions the bottom to close the inlet.
The outlet in an alternate embodiment most preferably includes a plug supported from the wall and within the outlet by a web so that when the flipped bulbous tube moves the plug axially through the passage. In that alternate configuration the plug contacts the seat and closes the inlet.
The wall about the inlet may in this version includes a pipe depending therefrom and into the passage so the seat is most preferably on the pipe away from the inlet. The seat on the pipe can be adapted to engage the plug for remotely closing the inlet. The inlet might include a duct positioned thereabout to surround the inlet and extend the passage away from the outlet, the duct, the flange and the bulbous tube are thus in this arrangement adapted for fluid communication with the body orifice.
The bulbous tube is preferred to be circular in cross section and substantially symmetrical about the axis and the inlet and outlet are substantially normal to the axis but need not be symmetric or circular. The bulbous tube could be formed of a flexible polymer by for example molding or casting. The outlet most preferably includes a grip projecting therefrom for use in pulling the outlet to flip the hinge and open the passage between the inlet and outlet.
A method of making a valve adapted for closing an orifice may include steps. Forming a bulbous tube of a flexible material may be a step. The step of having on the bulbous tube an inlet fixed for placement across the orifice and an outlet positioned away from the orifice is a step. The step of locating a flange with a generally flat ring shape around the inlet of the bulbous tube to interface about the orifice is preferably performed. Extending a passage within the bulbous tube from the inlet along an axis therethrough may be a preferred step. It is most preferred that having a barrel shaped wall on the bulbous tube with the wall tapering toward the inlet and the outlet and thus wider therebetween is a step. The wall between an inside and an outside.
Locating a hinge about the bulbous tube and in the wall as an area of preferential bending so the bulbous tube is either normally barrel shaped or flipped with the outlet folded about the hinge into the passage may be a step. The step of locating a seat on the inside of the wall to engage the outlet when the bulbous tube is flipped into the passage by bending the hinge acutely so the outlet is moved along the axis toward the inlet and held against the seat is in the method.
A method of using a valve may include the bulbous tube formed of a flexible material. The bulbous tube preferably has an inlet fixed across the orifice and an outlet opposite thereto. The bulbous tube has a barrel shape tapering toward the inlet and the outlet so the hinge about the bulbous tube. The hinge is an area of preferential bending so the bulbous tube is either normally barrel shaped or flipped with the outlet folded about the hinge. A seat within the bulbous tube seals the outlet. The method of using with the steps of flipping the bulbous tube by bending the hinge acutely so the outlet is moved toward the inlet and held against the seat. The method of using with the step of unfolding the acutely bent hinge. The method of using with the step of unfolding the acutely bent hinge by pressurizing the seat at the inlet but within the bulbous tube to unseal the outlet. The method of using with the step of unfolding the acutely bent hinge by pressing about the hinge to flip the outlet away from the seat.